vips presentation to dcvmn october 2019 v8 23oct19 · • the alliance vips initiative marion...

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Catalyzing product development of vaccine technology innovations: Vaccine Innovation Prioritisation StrategyMarion Menozzi-Arnaud, GaviDebra Kristensen, PATHBirgitte Giersing, WHO

October 2019

Catalyzing product development of vaccine technology innovations: Vaccine Innovation Prioritisation Strategy

Topic Presenter• The Alliance VIPS initiative Marion Menozzi, Gavi• Nine prioritised innovations from the VIPS initial

prioritisation phase Debra Kristensen, PATH

• Process for the final prioritisation phase Birgitte Giersing, WHO• Q&A Dr. Sotiris Missailidis • Panel discussion - ‘How VIPS may help drive vaccine

delivery innovations but what else is needed beyond the prioritisation and communication?’

Dominic Hein, Gavi

• Q&A Dr. Sotiris Missailidis

Agenda

Why is VIPS needed?

Innovative delivery approaches will be

needed to help achieve the Alliance coverage

and equity targets

The next decade will likely need to shift to sub-national use of

differentiated products

Many innovation initiatives across the Alliance, but strategy and effort not fully

aligned or coordinated

VIPS background and goal

2016 – 2020: Innovation as one

of the Alliance priorities for

shaping markets

VIPS

The Alliance aims to pursue a common agenda of driving vaccine product innovation

to better meet country needs and support Alliance

goals

Prioritise innovations in vaccine delivery attributes to provide greater clarity to

manufacturers and immunisation partners to make investment decisions

VIPS is a close Alliance-wide collaboration effort

VIPS will be delivered through two prioritisation phases by end Q1 2020

We are here

1 Purpose is to prioritise innovations “themselves”, “as platforms”, however it will be signaled for which individual vaccines or types of vaccines the innovation is seen to be most valuable.

24 innovations assessed

9 innovations

prioritised for Phase II

Phase I: Initial prioritisation of innovations

• Innovations’ characteristics andpotential public health value;

• Potential ‘breadth of use’ (applicability to several vaccines)

December 2018 – June 2019

AIM: Prioritise

~ 3 - 4innovations1

Phase II: Final prioritisation of innovations

paired with vaccines

July 2019 – March 2020

9 prioritised innovations

analysed with 17 priority vaccines

• Short-listed innovations further analysed with priority vaccines

24 vaccine product innovations are being assessed through the VIPS process

Integrated primary containers and delivery technologies

• Compact prefilled auto-disable devices (CPAD)• Single-chamber cartridge injectors• Dual-chamber delivery devices• Microarray patches (MAP)• Prefilled polymer BFS droppers/dispensers• Prefilled dry-powder intranasal devices • Solid-dose implants (with applicator)• Sub-lingual dosage forms• Oral fast-dissolving tablets

Delivery technologies (not pre-filled)

• AD sharps-injury protection (SIP) syringes

• Disposable syringe jet injectors (DSJI)

• ID syringes

Primary vaccine containers

(without delivery device)

• Blow-fill-seal (BFS) primary containers

• Dual chamber vials

Formulation• Heat stable/controlled temperature chain

(CTC) qualified liquid formulations• Heat stable/ CTC qualified dry formulations• Freeze damage resistant liquid

formulations

Labelling on primary packaging

• Freeze indicator on primary vaccine container

• Combined Vaccine vial Monitor (VVM) and Threshold Indicator (TI)

• Barcodes• Radio Frequency Identification

(RFID) labels

Packaging and safety

• Bundling devices• Reconstitution vial

adapters• Plastic needles (for

reconstitution)

VIPS methodology relies on a thorough evaluation process, centered on country needs

VIPS advised by a Steering

Committee of 17 independent experts, 9 are

members of WHO vaccine advisory

committees (PDVAC and IPAC)

Country consultations ensure that country needs drive the prioritisation

An analytical evaluation framework allows a transparent

and balanced assessment of

innovation benefits

a Product Development for Vaccines Advisory Committeeb Immunization Practices Advisory Committee

Evaluation framework for Phase ICriteria Indicators

Primary ranking criteria

Health Impact • Ability of the innovation to withstand heat exposure • Ability of the innovation to withstand freeze exposure

Coverage and Equity impact

• Ease of use• Potential to reduce stock outs based on the number of

separate components necessary to deliver the vaccine or improved ability to track vaccine commodities

• Acceptability of the innovation to patients/caregivers

Safety impact • Likelihood of contamination• Likelihood of needle-stick injury

Economic costs (i.e. Delivery and

Introduction and recurrent costs)

• Total cost of storage and transport of commodities per dose

• Total cost of the time spent by staff per dose• Total cost of introduction and recurrent costs (not

otherwise accounted for)

Secondary criteria

Potential breadth of innovation use

• Applicability of the innovation to one or several types of vaccines

• Ability of the innovation to facilitate novel vaccine combination

VIPS methodology includes 3 country consultations

Understanding country immunisation barriers

and needs (that can be addressed by

VIPS innovations)

• Online survey• Q4 2018• 500 complete

responses across 55 Gavi and non Gavi countries

Identifying vaccine-specific barriers and

needs (that can be addressed by

VIPS innovations)

• Online survey• Q4 2019 - Ongoing

Feedback on 9 short-listed innovations

under Phase I

• In-person in-depth interviews

• Q4 2019 - Ongoing• 10-15 people in 5-6

countries at national and subnational levels

Inputs are used for weighting indicators to inform the prioritisation

Beyond countries, VIPS also ensures alignment and engagement with existing committees and industry

2018 2019 2020Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec H1

Short-list of innovations Final prioritised innovations

SAGE

WHO PDVAC

WHO IPAC

Vaccine and technology developers/

manufacturers

Inputs/Feedback from selected manufacturers/developers based on data questions and gaps

Updates upon request

IFPMA

DCVMN

PATH/WHO DT-WG Consultations

Other interested parties (e.g. CEPI,

Wellcome, etc.)

9 innovations have been short-listed for Phase II based on…


9 innovations short-listed for Phase II

• Multiple public health benefits OR a strong unique benefit

• Broad antigen applicability• And/ or additional strategic

rationale for prioritisation

Note: Innovation pictures are just examples of innovations

9 innovations short-listed for further analysis under Phase II

Microarray patches (MAPs) Compact prefilled auto-disable devices (CPADs)

AD sharps-injury protection (SIP) syringes

Solid-dose implants Dual-chamber delivery devices Freeze damage resistant liquid formulations

Heat stable/controlled temperature chain (CTC) qualified liquid

formulations

Combined Vaccine vial Monitor (VVM) and Threshold Indicator (TI)

Barcodes / Radio Frequency Identification (RFID)

15 innovations have not been short-listed for Phase II …


9 innovations short-listed for Phase II

• Other innovations offered similar benefits, plus additional benefits

• Potential public health benefits but some challenges

• Limited antigen applicability

15 innovations not short-listed for Phase II

VIPS aspirational vision

Depending on Gavi 5.0 mandate and resources, the Alliance will consider how to support the prioritised innovations beyond prioritisation and signalling

Beyond prioritisation and signalling, the Alliance recognises the need to support development and/or uptake of the prioritised innovations

Support may be needed for: • Product development• Regulatory pathway• Country studies• Policy• Procurement• Implementation• Etc.


Topic Presenter• The Alliance VIPS initiative Marion Menozzi, Gavi

Nine prioritised innovations from the VIPS initial prioritisation phase

Debra Kristensen, PATH



Dominic Hein, Gavi


Agenda

Menti survey

Please open Menti.com on your web browser

Code : 92 39 8

1. Which of these 9 innovations are you familiar with? (Check all that apply.)

Mentimeter survey

part 1

https://www.mentimeter.com/s/165cea2b702477d310670c47e1cd60f2/69d30c74fe36

About Microarray patches (MAPs)

• MAPs contain an array of micro-projections on a patch that deliver dry vaccine into the epidermis and/or dermis layers.

• Administered without an applicator, by applying pressure with fingers, or using an integrated applicatora

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a Lead candidate MAPs for vaccine delivery either have no applicator or an integrated applicator. Therefore, MAPs with a separate applicator are not considered in this assessmentb http://micronbiomedical.com/technology/ ; c https://www.who.int/immunization/research/meetings_workshops/PDVAC_2017_Delivery_Tech_Update_Zehrung_PATH.pdf?ua=1


http://micronbiomedical.com/technology/

MAPs: Rationale for prioritisation

Potential to resolve reconstitution issues, multiple public health benefits, and broad applicability

Health Impact • Withstand heat and freeze exposure• Positively impact coverage and equity:

• Easier to use; use by lesser trained vaccinators or self-administration; alternative delivery scenarios

• Less painful• Reduce stock-outs

Safety impact • Reduced contamination/needlestick risk

Economic costs • Save health care worker time


• Broad applicability and might facilitate novel vaccine combination• Might also improve immunogenicity


MAPs have the potential to:

About Solid-dose implants (SDIs)

• Vaccines reformulated into a solid format, shaped like a needle to be implanted below the skin.

• Dose either dissolves immediately or is released slowly.

• Contained in a cartridge or cassette for easy handling prior to administration.

• Administered with an applicator to propel the SDI into the skin, separate and re-usable, or integrated and single use.

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Separate, compressed gas-powered applicator (Bioneedle)

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Separate, spring-powered applicator (Implavax®)

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Optional, separate applicator (MicropatchTM)

a Hirschberg HJHB, van de Wijdeven GGP, Kelder AB, van den Dobbelsteen GPJM, Kersten GFA. Bioneedles as vaccine carriers. Vaccine. 2008 May 2;26(19):2389–97. b https://www.enesipharma.com/technologies/platform/ ;c Nemaura presentation. Teriparatide microneedle patch for osteoporosis, December 2018. Presented during telecon 12 February 2019.


https://www.enesipharma.com/technologies/platform/

https://www.enesipharma.com/technologies/platform/

SDIs: Rationale for prioritisation

Potential multiple public health benefits and broad applicability. Potential to solve issues associated with MAPs. e.g. reactogenicity, payload issues

Health Impact • Withstand heat and freeze exposure• Positively impact coverage and equity:

• Easier to use: use by lesser trained vaccinators; alternative delivery scenarios

• Increased acceptability to standard needle and syringe• Reduce stock-outs




• Broad applicability to all parenteral vaccines and might facilitate novel vaccine combination


SDIs have the potential to:

About Compact prefilled auto-disable devices (CPADs)

• Integrated primary containers and injection devices prefilled with liquid vaccines.

• Design prevents reuse and minimizes the space required for storage and shipping.

Three CPAD subtypes have been assessed: • Preformed CPADs: Manufactured ‘open’, supplied sterile, ready to fill/seal by the vaccine

manufacturer.• Blow-fill-seal (BFS) CPADs: Manufactured using BFS automated technology; produced,

filled, and sealed in a continuous process.• Other CPAD types.

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Preformed CPAD (UnijectTM)

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Other CPAD (Easyject)

a https://drugdeliverysystems.bd.com/products/prefillable-syringe-systems/vaccine-syringes/uniject-auto-disable-pre-fillable-injection-system; b http://injecto.eu/easyject/


https://drugdeliverysystems.bd.com/products/prefillable-syringe-systems/vaccine-syringes/uniject-auto-disable-pre-fillable-injection-system

http://injecto.eu/easyject/

CPADs: Rationale for prioritisation

Potential multiple public health benefits, broad applicability and proven benefits in facilitating vaccine outreach

Health Impact • Positively impact coverage and equity:• Easier to use: use by lesser trained vaccinators; alternative

delivery scenarios• Increased acceptability of UnijectTM preformed CPADs • Reduce stock-outs


Economic costs • Save health care worker time• Reduce storage and transportation costs

Potential breadth of innovation use • Broad applicability to all liquid, parenteral vaccines


CPADs have the potential to:

About Dual-chamber delivery devices

• Dual chamber delivery devices are fully integrated reconstitution technologies.

• Prefilled with liquid and dry vaccine components, which are mixed within the device and administered.

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Dual chamber syringe (Vetter Lyoject)

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Dual chamber blister with frangible seal

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Dual chamber blister with frangible seal

a https://www.pharmaceutical-networking.com/vetter-dual-chamber-delivery-systems/ b https://www.pharmapan.com/sites/default/files/downloads/2017-10/PHARMAPAN_Dual_Chamber_Blister_1.1.pdfc https://www.webpackaging.com/en/portals/webpac/assets/11138717/neopacs-fleximed-now-in-large-format/


http://www.pharmaceutical-networking.com/

https://www.pharmaceutical-networking.com/vetter-dual-chamber-delivery-systems/

https://www.pharmapan.com/sites/default/files/downloads/2017-10/PHARMAPAN_Dual_Chamber_Blister_1.1.pdf

https://www.webpackaging.com/en/portals/webpac/assets/11138717/neopacs-fleximed-now-in-large-format/

https://www.webpackaging.com/en/portals/webpac/assets/11138717/neopacs-fleximed-now-in-large-format/

Dual-chamber delivery devices: Rationale for prioritisationPotential to resolve reconstitution issues, multiple public health benefits and

broad applicability

Health Impact • Positively impact coverage and equity:• Easier to use• Reduce vaccine and diluent wastage and stock-outs and

simplify inventory processes• Increase acceptability: reduce the risk of reconstitution with the

wrong diluent



Potential breadth of innovation use • Broad applicability to dry and other two-component vaccines.


Dual-chamber delivery devices have the potential to:

About Autodisable (AD) sharps-injury protection (SIP) syringes

• Single-use, disposable syringes with a mechanism that covers the needle after use to reduce the risk of accidental needlestick injury.

• Retraction of the needle into the barrel after injection or a needle shield.

• Some syringes have SIP features that are automatically activated and others require extra activation steps by the end user.

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BD Eclipse™ syringe (BD, Franklin Lakes, NJ) with needle shield


AD SIP syringes: Rationale for prioritisation

Single public health benefit attributed to improved safety.WHO Performance, Quality, and Safety group plans to require SIP features on both

AD and reuse prevention syringes by the end of 2020.

Safety impact • Improve safety due to reduced risk of contamination and needle-stick injuries/transmission of bloodborne pathogens


• Broad applicability as AD SIP syringes can be applied to all parenteral vaccines

AD SIP syringes have the potential to:

About Freeze damage resistant liquid formulations

• For many vaccines, when frozen the antigen-adjuvant particles agglomerate and sediment - resulting in the irreversible loss of potency.

• Developing novel freeze-stable formulations using different excipients (stabilising agents) could prevent agglomeration and stabilise the potency of vaccines.

• The addition of excipients has been demonstrated to reduce the freeze-sensitivity of hepatitis B vaccine and other vaccines containing aluminum-salt adjuvants including diphtheria, tetanus and pertussis (DTP); and pentavalent (hepatitis B, DTP, Haemophilusinfluenza type b) vaccines.

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Freeze damage resistant liquid vaccines

a https://www.myelomacrowd.org/wp-content/uploads/2015/05/vials.jpgb https://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/Infection-Prevention-and-Control-for-Clinical-Office-Practice-Multidose-Vials.aspx


Freeze damage resistant liquid formulations: Rationale for prioritisation

Safeguards vaccine potency and prevents vaccine wastage.Prioritisation could raise the visibility of the technology to vaccine manufacturers

currently developing liquid vaccines with aluminum adjuvants.

Health Impact• Improve freeze resistance of liquid formulations

• Safeguard the potency of the vaccine if accidentally exposed to freezing temperatures and help to prevent vaccine wastage


• Broad applicability to all liquid vaccines containing aluminum-salt adjuvant and potentially to other freeze-sensitive vaccines

Freeze damage resistant liquid formulations have the potential to:

About Heat stable/controlled temperature chain (CTC) qualified liquid formulations

• Liquid vaccine formulations that are sufficiently heat stable to be kept in a CTC.

• CTC use of vaccines allows for single excursion of the vaccine into ambient temperatures not exceeding +40°C for a minimum of 3 days, just prior to administration.

• Heat-stable vaccines differ in the length of time they can be stored in a CTC and the maximum temperature they can endure while remaining stable and potent.

• CTC qualification involves regulatory approval and prequalification by WHO.


Heat stable/CTC qualified liquid formulations: Rationale for prioritisation

Potential multiple public health benefits and WHO recommended

Health Impact • Improve vaccine effectiveness: less susceptible to heat damage• Reduce likelihood of freeze exposure• Positively impact coverage and equity:

• Easier to use ; alternative delivery scenarios; ease cold chain logistics for health care workers

• Increase acceptability• Reduce stock-outs


Economic costs • Reduce storage and transportation volume and associated costs• Save health care worker time


• Broad applicability to all vaccines that are currently liquid and thermostable


Heat stable/CTC qualified liquid formulations have the potential to:

About Combined Vaccine Vial Monitor (VVM) and Threshold Indicators (TI)

• Combined VVM-TIs on primary containers undergo gradual colour change up to a specified peak threshold temperature and rapidly react if exposed at or above the threshold temperature.

• Currently, VVMs and TIs are not integrated:

• VVMs on primary containers and standalone TIs are currently used when vaccines are kept in a controlled temperature chain (CTC)

• TIs purchased and distributed separately from the vaccine and kept at temperatures below their threshold

• VVM response not rapid enough at higher temperatures (e.g. >37°C or 40°C), whereas TI reacts rapidly if exposed at or above a defined threshold temperature.

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Reading of integrated VVM-TI

• There are two types of combined VVM-TIs:

• VVM and TI placed together and reviewed separately• TI is integrated into the VVM: looks and is interpreted

identically to the existing VVMs.Note: Innovation pictures are just examples of innovations

Combined VVM and TIs: Rationale for prioritisation

Potential to improve upon the current use of VVMs with separate TI indicators. Potential to facilitate use of vaccines in a CTC.

Health Impact• Positively impact coverage and equity:

• Easier to use• Provide more accurate assessment of the heat exposure status

of a vaccine, particularly when used in the CTC• Reduce TI stock-outs



• Broad applicability to all vaccines, even if likely to be most useful for vaccines prequalified for use in a CTC


Combined VVM and TIs have the potential to:

About Barcodes

• Encode information such as product numbers, serial numbers, supplier data, batch numbers and expiry dates.

• Scanned electronically using two dimensional (2D) scanners, laser or mobile device cameras to automatically capture information.

• Enable tracking and monitoring of vaccine products in supply chains.

• Possibility to automatically import data into patient electronic medical records (EMRs).

• VIPS assessment based on barcode placement on vaccine primary and higher packaging levels.

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a https://www.newswire.ca/news-releases/sanofi-pasteur-moves-national-immunization-strategy-forward-with-new-bar-code-technology-509575151.html


https://www.newswire.ca/news-releases/sanofi-pasteur-moves-national-immunization-strategy-forward-with-new-bar-code-technology-509575151.html

About Radio Frequency Identification (RFID)

• RFID tags can be affixed to vaccine primary containers.

• Store a wide range of information useful for inventory control, patient monitoring and providing data for electronic medical record systems.

• An RFID system consists of three components; (i) a tag, (ii) a reader and (iii) the middleware.

• Possibility to identify tags within range – no need to individually scan every tag.

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Handheld RFID readers & scanners

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RFID tags used for hospital medication trays

a http://endtimestruth.com/wp-content/uploads/2014/01/RFID-chip-and-antenna-3.pngb http://ww1.prweb.com/prfiles/2014/10/05/12223944/HCL%20-%20Seal%20Tags%20Kit%20Check.jpgc https://www.abr.com/products/rfid-products/


http://endtimestruth.com/wp-content/uploads/2014/01/RFID-chip-and-antenna-3.png

http://ww1.prweb.com/prfiles/2014/10/05/12223944/HCL%20-%20Seal%20Tags%20Kit%20Check.jpg

Barcodes and RFIDs:Rationale for prioritisation

Potential to improve coverage and increase measurement of coverage and safety monitoring. WHO recommendations and UNICEF interest.

Health Impact • Positively impact coverage and equity:• Reduce missed opportunities; increase acceptability by

improving patient safety• Reduce stock-outs: improve traceability ; increase efficiencies in

stock management



• Barcodes and RFIDs could be applied to all vaccines, there are no restrictions based on technical feasibility.


Barcodes and RFIDs have the potential to:

Menti survey

Please open Menti.com on your web browser

Code : 92 39 8

2. Which innovations are of most interest to your organization ?

Mentimeter survey

part 2

https://www.mentimeter.com/s/165cea2b702477d310670c47e1cd60f2/69d30c74fe36







Dominic Hein, Gavi


Agenda

Under Phase II the 9 short-listed innovations will be further analysed for final prioritisation of 3-4 innovations



9 innovations prioritised for

Phase II



AIM: Prioritise

~ 3 - 4innovations1



July 2019 – March 2020



Short-listed innovations will be

further analysed with 17 priority vaccines

Landscape of vaccines in VIPS scope

Landscape snapshot of antigen categorisation to map overlap

Distribution of the 17 priority vaccines for Phase II within the landscape of 48 vaccines

Evaluation framework for Phase II (1/2)Criteria Indicators

Primary ranking criteria

Health Impact

• Vaccine efficacy• Vaccine effectiveness• Ability of the innovation to withstand heat exposure1

• Ability of the innovation to withstand freeze exposure1

Coverage and equity

impact

• Number of fully or partially immunised individuals (relative to target pop)• Ease of use2

• Presentation which helps prevent missed opportunities due to reluctance to open MDV without preservative

Safety impact• Number of vaccine product-related adverse events• Likelihood of contamination2

Economic costs(i.e. Commodity,

Delivery and Introduction and recurrent costs)

• Total cost of a vaccine regimen with the innovation, including wastage• Total cost of delivery technology(ies) used for the vaccine regimen,

including wastage • Total cost of safety boxes used for the vaccine regimen, incl wastage• Total cost of storage and transport of commodities (per vaccine regimen)1

• Total cost of the time spent by staff (per vaccine regimen)1

• Total cost of introduction and recurrent costs (not otherwise accounted for)1

1 Same indicators as for Phase I but further assessed under Phase II due to the antigen/vaccine pairing2 This indicator is re-assessed in Phase II only when the comparator for a specific vaccine is a MDV, requiring a new evaluation – The comparator SDV is assessed in Phase I

Evaluation framework for Phase II (2/2)

Criteria Indicators

Secondaryranking criteria1

Technology readiness

• Clinical development pathway complexity • Technology development challenges• Regulatory pathway complexity• Complexity of manufacturing the innovation• Robustness of the innovation pipeline

Commercialfeasibility

• Potential breadth of market size• Existence of partnerships to support development and

commercialisation• Known barriers to global access to the innovation• Stakeholders’ interest

1 These criteria will be evaluated in an absolute manner, not relative to a comparator.

In Phase II, VIPS is engaging with the Delivery Technologies Working Group (DT-WG)

• Platform for industry and the public sector to engage on the presentation, packaging, and delivery aspect of vaccine products.

• Inform industry about LMIC programmatic preferences & operational realities.

• Optimise innovation of immunisation products for public-sector use.

• Sensitize the public sector to industry constraints and economic realities of investing in product development.

• Update broader set of immunisation stakeholders, including industry, on VIPS.

• Obtain feedback on VIPS prioritised innovations from the perspective of technical feasibility, manufacturability, regulatory hurdles.

DT-WG goals and objectives Consultations objectives

A final report will be published by Q3/Q4 2020



Publication of a final report: • Process and

methodology; • Most valuable

innovations including rationale, recommendations;

• Inform research agenda.

• All assessments will be made public.

April-December 2020July 2019 – March 2020


9 innovations prioritised for

Phase II


AIM: Prioritise

~ 3 - 4innovations1











Dominic Hein, Gavi


Agenda

vips presentation to dcvmn october 2019 v8 23oct19 · • the alliance vips initiative marion...

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